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leader flu and severe cold and cough

Dosage form: powder, for solution
Ingredients: ACETAMINOPHEN 650mg, DEXTROMETHORPHAN HYDROBROMIDE 20mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Cardinal Health
NDC Code: 37205-678

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Cardinal Health Flu & Severe Cold & Cough Drug Facts

Active ingredients (in each packet)

Acetaminophen 650 mg

Dextromethorphan hydrobromide 20 mg

Phenylephrine hydrochloride 10 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses
 
temporarily relieves
 
minor aches and pains
 
minor sore throat
 
headache
 
nasal and sinus congestion
 
cough due to minor throat and bronchial irritation
 
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

 
more than 6 packets in 24 hours, which is the maximum daily amount for this product
 
with other drugs containing acetaminophen
 
3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use
 
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
 
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
 
liver disease
 
heart disease
 
high blood pressure
 
thyroid disease
 
diabetes
 
trouble urinating due to an enlarged prostate gland
 
cough that occurs with too much phlegm (mucus)
 
cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
 
a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product
 
do not exceed recommended dosage

Stop use and ask a doctor if
 
you get nervous, dizzy or sleepless
 
fever gets worse or lasts more than 3 days
 
redness or swelling is present
 
new symptoms occur
 
pain, cough or nasal congestion gets worse or lasts more than 7 days
 
cough comes back or occurs with fever, rash or headache that lasts.
These could be signs of a serious condition.
 

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
 
do not use more than directed – see Liver warning
 
take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor
 
adults and children 12 years of age and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
 
children under 12 years of age: consult a doctor
 
if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.
 

Other information
 
each packet contains: potassium 5 mg and sodium 41 mg
 
phenylketonurics: contains phenylalanine 17 mg per packet
 
store at 20°-25°C (68°-77°F)
 

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Theraflu® Severe Cold & Cough active ingredients

Flu & Severe Cold & Cough

Daytime

Pain Reliever – Fever Reducer (Acetaminophen)

Cough Suppressant (Dextromethorphan HBr)

Nasal Decongestant (Phenylephrine HCl)

NASAL & SINUS CONGESTION

COUGH

BODY ACHE

SORE THROAT PAIN

HEADACHE

FEVER

Berry Infused with Menthol & Green Tea Flavors

LEADER FLU AND SEVERE COLD AND COUGH 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-678
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ANHYDROUS CITRIC ACID 
ASPARTAME 
SILICON DIOXIDE 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
MALTODEXTRIN 
SODIUM CITRATE 
SUCROSE 
TRIBASIC CALCIUM PHOSPHATE 
Packaging
#Item CodePackage Description
1NDC:37205-678-916 POWDER, FOR SOLUTION in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/13/2012
Labeler - Cardinal Health (097537435)

Revised: 08/2012
 
Cardinal Health

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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